MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN; INTRAVASCULAR CATHETER

Model Number 383536

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 1102712.Medical device expiration date: 2024-03-31.Device manufacture date: 2021-04-12.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using bd nexiva¿ closed iv catheter system - dual port 20 ga 1.00 in rust was found on the needle.The following information was provided by the initial reporter: (b)(6) 2021 in regards to bd nexiva 20g 1inch 383536 that the needle has rust.

Event Description

It was reported while using bd nexiva¿ closed iv catheter system - dual port 20 ga 1.00 in rust was found on the needle.The following information was provided by the initial reporter: 9th feb in regards to bd nexiva 20g 1inch 383536 that the needle has rust.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 3/3/2022.H.6.Investigation: our quality engineer inspected the samples submitted for evaluation.Bd received two 20g x 1.00in.Nexiva units, one from lot number 1102712 and one from lot number 1137220.There was no evidence of media present on the units, but they were returned with the needles retracted into the tip shield.A gross visual inspection of the returned units did not identify any foreign matter.The components of both units were further inspected using an eye loop and a microscope.No foreign matter, including rust, was identified.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failures stated in the report.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13563213
• MDR Text Key: 286497012
• Report Number: 1710034-2022-00084
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835363
• UDI-Public: 30382903835363
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383536
• Device Catalogue Number: 383536
• Device Lot Number: 1137220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1